Human Diabetes

Insulin ELISA (10-1113-01/10)

A high quality ELISA for specific measurement of human insulin in serum, plasma or cell culture media.

Kit format: 1 x 96 or 10 x 96 wells
Measurement range: 3 – 200 mU/L (0.13 – 8.70 µg/L)

  • Calibrated against 1st International Reference Preparation 66/304 for human insulin
  • No cross-reactivity to C-peptide or Proinsulin des(31-32) or split (32-33)
  • Insignificant or no cross-reactivity to insulin analogs
  • CE/IVD labeled on select markets

Test Characteristics

Samples: Serum, plasma, cell culture media
Sample volume: 25 µL
Assay range: 3 – 200 mU/L
Detection limit: ≤ 1 mU/L (0.043 µg/L)
Incubation: 1 h + 15 min
Detection method: absorbance

Specificity:

The following cross-reactions have been tested:

C-peptide <0.01 %
Proinsulin <0.01 %
Proinsulin des (31-32) <0.5 %
Proinsulin split (32-33) <0.5 %
Proinsulin des (64-65) 98 %
Proinsulin split (65-66) 56 %
Insulin aspart 4 %
Insulin detemir n.d.
Insulin glargin 24 %
Insulin glulisine n.d.
Insulin lispro n.d.
IGF-I <0.02 %
IGF-II <0.02 %
Rat insulin 0.7 %
Mouse insulin 0.3 %
Porcine insulin 93 %
Ovine insulin 48 %
Bovine insulin 31 %

n.d.=not detected

Directions for use.

Iso-Insulin ELISA (10-1128-01)

Mercodia Iso-Insulin ELISA provides a method for the quantitative determination of total insulin.

Kit format: 1 x 96 wells
Measurement range: 3 – 100 mU/L (0.13 – 4.35 µg/L)

  • Measures total insulin
  • Cross-reactivity with most insulin analogs
  • Calibrated against 1st International Reference Preparation 66/304 for human insulin.
  • CE/IVD labeled on select markets

Test Characteristics

Samples: Serum, plasma, cell culture medium
Sample volume: 25 µL
Assay range: 3 – 100 mU/L
Detection limit: 2 mU/L (0.086 µg/L)
Incubation: 1 h + 15 min
Detection method: absorbance

Specificity

The following cross-reactions have been tested:

Insulin 100 %
C-peptide < 0.1 %
Proinsulin 54 %
Proinsulin des (31-32) 58 %
Proinsulin split (32-33) 56 %
Proinsulin des (64-65) 66 %
Proinsulin split (65-66) 78 %
Insulin lispro 112 %
Insulin aspart 100 %
Insulin determir 28 %
Insulin glargine 58 %
Insulin glulisine 123 %
IGF-I < 0.02 %
IGF-II < 0.02 %
Rat insulin 71 %
Mouse insulin 49 %
Porcine insulin 76 %
Ovine insulin 131 %
Bovine insulin 58 %

Directions for use.

Ultrasensitive Insulin ELISA (10-1132-01)

A high quality enzyme immunoassay for specific quantification of human insulin in serum or plasma.

Kit format: 1 x 96 wells
Measurement range: 0.15 – 20 mU/L (0.0065 – 0.87 µg/L)

  • Calibrated against 1st International Reference Preparation 66/304 for human insulin
  • No cross-reactivity to C-peptide or Proinsulin des(31-32) or split (32-33)
  • Insignificant or no cross-reactivity to insulin analogs
  • CE/IVD labeled on select markets

Test Characteristics

Samples: Serum, plasma
Sample volume: 25 µL
Assay range: 0.15 – 20 mU/L
Detection limit: ≤ 0.15 mU/L (0.0065 µg/L)
Incubation: 1 h + 30 min
Detection method: absorbance

Specificity

The following cross-reactions have been tested:

C-peptide <0.01 %
Proinsulin <0.01 %
Proinsulin des (31-32) <0.5 %
Proinsulin split (32-33) <0.5 %
Proinsulin des (64-65) 98 %
Proinsulin split (65-66) 56 %
Insulin aspart 3 %
Insulin detemir n.d.
Insulin glargine 12 %
Insulin glulisine n.d.
Insulin lispro n.d.
IGF-I <0.02 %
IGF-II <0.02 %
Rat insulin 0.7 %
Mouse insulin 0.3 %
Porcine insulin 93 %
Ovine insulin 48 %
Bovine insulin 31 %

n.d.=not detected

Directions for use.

C-peptide ELISA specific (10-1136-01)

A high quality immunoassay for specific quantification of human C-peptide in serum, plasma or urine.

Kit format: 1×96 wells
Measurement range: 100 – 4000 pmol/L (0.302 – 12.1 µg/L)

  • Calibrated against International Reference Reagent IRR84/510 for human C-peptide
  • High specificity enables measurement of human C-peptide in mouse and rat models
  • Little or no cross-reactivity to human insulin or proinsulin
  • CE/IVD labeled on select markets
Test Characteristics
Samples: serum, EDTA and heparin plasma or urine

Sample volume: 25 µL
Assay range: 100-4000 pmol/L (0.3-12.0 ng/mL)
Detection limit: ≤ 25 pmol/L (0.076 μg/L)
Incubation: 1h + 1h + 15 min
Detection method: absorbance

Specificity

The following cross-reactions have been tested:

Insulin < 0.0006 %
Proinsulin 2 %
Proinsulin (Des 31-32) 3 %
Proinsulin (Split 32-33) 2 %
Proinsulin (Des 64-65) 74 %
Proinsulin (Split 65-66) 10 %

Directions for use.

Ultrasensitive C-peptide ELISA (10-1141-01)

The Mercodia Ultrasensitive C-peptide ELISA is a high quality immunoassay for specific quantification of human C-peptide in serum, plasma, cell culture media or urine.

Kit format: 1 x 96 wells
Measurement range: 5 – 280 pmol/L (0.015 – 0.85 ng/mL)
  • High sensitivity, detetction limit < 2.5 pmol/L (0.0076 µg/L)
  • No or minimal cross-reactivity to insulin or proinsulin
  • Calibrated against International Reference Reagent IRR84/510 for human C-peptide.
  • CE/IVD labeled on select markets

Test Characteristics

Samples: Serum, EDTA and heparin plasma as well as urine.

Sample volume: 50 µL
Assay range: 5 – 280 pmol/L (0.015 – 0.85 ng/mL)
Detection limit: 2.5 pmol/L (0.0076 µg/L)
Incubation: 1 h + 1 h + 30 min
Detection method: absorbance

Specificity

The following cross-reactions have been tested:

Insulin < 0.0006 %
Proinsulin 5 %
Proinsulin (Des 31-32) 3 %
Proinsulin (Split 32-33) 2 %
Proinsulin (Des 64-65) 74 %
Proinsulin (Split 65-66) 10 %

Directions for use.

Proinsulin ELISA (10-1118-01)

Mercodia Proinsulin ELISA provides a method for the quantitative determination of human proinsulin in serum or plasma.

Kit format: 1 x 96 wells

Measurement range: 3.3 – 130 pmol/L (0.03 – 1.18 µg/L)
  • Measures total proinsulin
  • Calibrated against International Reference Reagent IRR 84/611 for human proinsulin
  • Highly specific with no cross-reactivity to human insulin or C-peptide

Test Characteristics

Samples: Serum and plasma
Sample volume: 50 µL
Assay range: 3.3 – 130 pmol/L
Detection limit: 1.7 pmol/L
Incubation: 1 h + 1 h + 15 min
Detection method: absorbance

Specificity

The assay is highly specific with no cross-reactivity to human insulin or C-peptide.

The following cross-reactions have been tested:

Insulin < 0.03 %
C-peptide < 0.006 %
Proinsulin (Des 31-32) 95 %
Proinsulin (Split 32-33) 95 %
Proinsulin (Des 64-65) 84 %
Proinsulin (Split 65-66) 90 %
Porcine Proinsulin 4 %
Mouse Proinsulin I 3 %
Mouse Proinsulin II 16 %
Rat Proinsulin I 13 %
Rat Proinsulin II 10 %

Directions for use.

Glucagon ELISA (10-1271-01)

The Mercodia Glucagon ELISA is a CE/IVD-labelled, highly specific and sensitive immunoassay for measuring glucagon in plasma and serum.

Kit format: 1 x 96 wells
Measurement range: 1.5 – 130 pmol/L (5 – 453 pg/mL)

  • Sample volume: 25 µL
  • No purification of samples
  • Sample types: Serum, EDTA Plasma, and cell-culture medium
  • Measurement range: 1.5 – 130 pmol/L (5.95 – 453pg/mL)
  • Detection limit: 0.75 pmol/L (2.61 pg/mL)
  • No cross-reactivity to glicentin, proglucagon 1-16, and glucagon 3-29
  • Highly appreciated and often cited assay
  • CE/IVD labeled on select markets

Test Characteristics

Samples: Serum, EDTA plasma and cell culture medium.
Sample volume: 25 µL
Assay range: 1.5-130 pmol/L (5.95-453pg/mL)
Detection limit: 0.75 pmol/L
Incubation: 18-22 h (overnight) + 1 h, 30 min
Detection method: absorbance

Specificity

The following cross-reactions have been tested:

Glicentin n.d
Oxyntomodulin 4.0 %
Proglucagon 1-61 n.d
Glucagon 3-29 n.d

Directions for use.

Glicentin ELISA (10-1273-01)

The Mercodia Glicentin ELISA is a high quality immunoassay for the quantification of human glicentin in serum, plasma and cell culture media.

Kit format: 1×96 wells
Measurement range: 3 – 300 pmol/L (24 – 2400 pg/mL)

  • Highly specific, sensitive and rapid method for determination of glicentin
  • No cross-reactivity to circulating proglucagon derived gut peptides
  • Assay buffers and calibrators have been optimized to prevent degradation and aggregation of glicentin

Test Characteristics

Samples: Serum, EDTA plasma and cell culture media
Sample volume: 25 µL
Assay range: 3 – 300 pmol/L (24-2400 pg/mL)
Detection limit: 3 pmol/L (24 pg/mL)
Incubation: 1 h + 1 h + 15 min
Detection method: absorbance

Specificity

The following cross-reactions have been tested:

Glucagon N.D.
Oxyntomodulin N.D.
Mini-glucagon N.D.
GLP-1 N.D
GLP-2 N.D.
Rat glicentin 0.9 %
Mouse glicentin N.D

N.D = Not detected

Directions for use.

Total GLP-1 NL-ELISA (10-1278-01)

Mercodia Total GLP-1 NL-ELISA provides a chemiluminescent method for the quantitative determination of amidated GLP-1 (glucagon-like-peptide-1) in human serum or plasma samples.

Kit format: 1×96 wells
Measurement range: 0.9 – 940 pmol/L (2.8 – 2940 pg/mL)

  • 100% specificity to the predominating isoform, GLP-1 (9-36) amide
  • High sensitivity
  • Validated according to CLSI/FDA/EMA

Test Characteristics

Samples: Human serum and EDTA plasma
Sample volume: 25 µL
Assay range: 1 – 940 pmol/L
Detection limit: 0.65 pmol/L
Incubation: 2h + 15 min
Detection method: chemiluminescence

Specificity

The following cross-reactions have been tested:

GLP-1 (1-36) amide 88%
GLP-1 (7-36) amide 93%
GLP-1 (9-36) amide 100%
GLP-1 (1-37) n.d.
GLP-1 (7-37) n.d.
Glucagon n.d.
GIP n.d.
GLP-2 n.d.
Oxyntomodulin n.d.
Glicentin n.d.
Miniglucagon n.d.
MPGF n.d.
Liraglutide n.d.
Exenatide n.d.
Lixisenatide n.d.
Dulaglutide 0.07%

n.d. = not detectable

Directions for use.

 

Lispro NL-ELISA (10-1291-01)

Mercodia Lispro NL-ELISA is designed to be an excellent assay for pharma use. It provides a chemiluminescent method for the quantitative determination of insulin lispro.

Kit format: 1 x 96 wells
Measurement range: 1 – 500 mU/L

  •  Optimized for pharma use
  • No cross-reactivity to endogenous insulin or other insulin analogs e.g. glargine
  • No interference from insulin auto-antibodies
  • Fully validated for use with human and pig samples, partially validated for rat samples
  • Controls included in the kit

Test Characteristics

Samples: human and porcine serum, EDTA plasma and P-800 plasma
Sample volume: 10 µL
Assay range: 1 – 500 mU/L
Detection limit: 0.36 mU/L
Incubation: 1h + 1h + 10 min
Detection method: Chemiluminescence

Specificity

The following cross-reactions and interferences were studied:

Human insulin N.D.
Human proinsulin N.D.
Glargine N.D.
Glargine M1 N.D.
Glargine M2 N.D.
Degludec N.D.
Determir N.D.
Insulin NPH N.D.
Aspart N.D.
Glulisine N.D.
Porcine insulin N.D.
Porcine proinsulin N.D.

N.D. = Not Detected

Directions for use.

Total GIP NL-ELISA (10-1258-01)

The Mercodia Total GIP NL-ELISA provides a method for the quantitative determination of GIP in human samples.

 Kit format: 1 x 96 wells
Measurement range: 2.7 – 1000 pmol/L

  • Measures both active GIP(1-42) and the inactive isoform GIP(3-42) in total
  • Broad measuring range
  • High sensitivity

Test Characteristics

Samples: Human serum and EDTA plasma
Sample volume: 25µL
Assay range: 2.7 – 1000 pmol/L
Detection limit: 1.62 pmol/L
Incubation: over night
Detection method: chemiluminescence

Specificity

The following cross-reactions have been tested:

GIP(1-42) 114-124%
GIP(3-42) 100%
GIP(1-30) n.d
GIP(3-30) n.d
Glucagon n.d
GLP-1(9-36)amide n.d
GLP-2 n.d
Oxyntomodulin n.d
Glicentin n.d
Miniglucagon n.d
Proglucagon 1-61 n.d
MPGF n.d
PACAP-38 n.d

n.d = not detected

Directions for use.

Controls

Diabetes Antigen Control - Human Low and High (10-1164-01)

Mercodia Diabetes Antigen Control is designed to be used as a two-level control for human insulin, C-peptide and proinsulin. It is manufactured from human serum and human insulin, C-peptide and proinsulin.

Kit format: 2 x 0.5 mL
Measurement range: n/a 

  • Easy transport – Lyophilized serum
  • Easy-to-use – Reconstituted with redistilled water
  • CE/IVD labelled on selected markets

Test Characteristics

Perform the Mercodia Insulin, C-peptide and Proinsulin ELISA assays according to the Directions for Use, handling Mercodia Diabetes Antigen Controls as samples.

Specificity

Each Mercodia Diabetes Antigen Control contains 2 vials of lyophilized serum, each containing 0.5 mL after reconstitution.

Directions for use.

GLP-1 (9-36) amide Control - Low, Medium, High (10-1287-01)

Mercodia GLP-1 (9-36) amide Control – Low, Medium, High is a three-level control for Mercodia Total GLP-1 NL-ELISA (10-1278-01).

Kit format: 3 x 0.5mL
Measurement range: n/a

  •  Easy to transport – Lyophilized serum
  • Easy to use – Reconstitute with redistilled water

Test Charateristics

Perform the Mercodia Total GLP-1 NL-ELISA, 10-1278-01, according to the Directions for Use of the assay handling Mercodia GLP-1 (9-36) amide Control (Low, Medium, High) as samples.

Specificity

Each Mercodia GLP-1 (9-36) amide Control (Low, Medium, High) contains 3 vials of stabilized serum controls. The content of each vial is lyophilized, containing 500 µL after reconstitution.

Directions for use.

Glucagon Control – Low, Medium, High (10-1286-01)

Mercodia Glucagon Control – Low, Medium, High is a three-level control for Mercodia Glucagon ELISA (10-1271-01) and Mercodia Glucagon ELISA -10µL (10-1281-01).

Kit format: 3 x 0.5mL

Measurement range: n/a

Directions for use.

Diabetes Sample Buffer (10-1195-01)

A dilution buffer that can be used in several Mercodia ELISAs – all insulin assays, all proinsulin assays and Rat C-peptide ELISA.

Kit format: 1 x 30 mL
Measurement range: n/a